Track­ing a suc­cess­ful DL­B­CL as­sault in Phase II, Mor­phoSys sets out to seize quick OK for MOR208

En­cour­aged by a break­through des­ig­na­tion at the FDA and its lat­est batch of up­beat da­ta from a Phase II study of its an­ti-CD19 an­ti­body MOR208, Mor­phoSys says it’s blaz­ing a straight path to reg­u­la­tors in search of an ac­cel­er­at­ed ap­proval.

Mor­phoSys ex­ecs spent a good deal of time talk­ing to an­a­lysts yes­ter­day about their rea­sons for shoot­ing at a quick OK. The Ger­man biotech high­light­ed up­dat­ed da­ta demon­strat­ing that of the 68 evalu­able pa­tients in their study for dif­fuse large B cell lym­phoma — a pop­u­lar dis­ease tar­get in on­col­o­gy — they tracked a 49% over­all re­sponse rate and a 31% com­plete re­sponse rate.

They al­so have a pre­lim­i­nary pro­gres­sion free sur­vival rate of 50.5% at 12 months.

Malte Pe­ters

This is a sin­gle arm study of the Mor­phoSys an­ti­body com­bined with lenalido­mide for 81 DL­B­CL pa­tients not el­i­gi­ble for high-dose chemo or au­tol­o­gous stem cell trans­plan­ta­tion. And it says a lot about why biotechs are bar­rel­ing in­to can­cer with high ex­pec­ta­tions of break­ing new ground ear­li­er than ever.

Malte Pe­ters, the chief de­vel­op­ment of­fi­cer at Mor­phoSys, spelled it out for an­a­lysts:

Specif­i­cal­ly 29 out of 33 pa­tients which have re­spond­ed, that amount to 88% are on­go­ing, 20 of whom have an on­go­ing com­plete re­sponse. The mean time to re­spond was short with 1.8 months and the mean time to ex­pe­ri­ence a com­plete re­sponse was 3.6 months….

At this time, we are hop­ing to be able to sub­mit da­ta from the cur­rent L-MIND tri­al to the FDA as a ba­sis for reg­u­la­to­ry ap­proval. Our goal is to achieve an ac­cel­er­at­ed ap­proval based pri­mar­i­ly on the L-MIND study. Apart from L-MIND, we are cur­rent­ly in­ves­ti­gat­ing MOR208 in the same pa­tient pop­u­la­tion in our Phase III B-MIND tri­al. This is a head-to-head study in­ves­ti­gat­ing the ef­fi­ca­cy of MOR208 plus ben­damus­tine ver­sus rit­ux­imab plus ben­damus­tine. Rit­ux­imab plus ben­damus­tine is one of the most com­mon­ly used reg­i­mens in the re­lapse re­frac­to­ry DL­B­CL set­ting.

The FDA al­ready has this drug down in the spe­cial BTD path based on an ear­li­er snap­shot of da­ta from the same study. That gives Mor­phoSys a rea­son­able hope that it can move fast to­ward a fil­ing while lin­ing up the big­ger Phase III as a con­fir­ma­to­ry study.

Si­mon Mo­roney

At this point, the ac­cel­er­at­ed ap­proval path­way has been blazed by a mob of de­vel­op­ers who need­ed to show that they were do­ing a rea­son­able per­cent­age of late-stage pa­tients some good. The FDA has re­spond­ed with alacrity, and reg­u­la­tors in the US are on­ly pick­ing up even more speed un­der the di­rec­tion of FDA com­mis­sion­er Scott Got­tlieb. Mor­phoSys – al­lied with a group of A-list part­ners on oth­er drugs – has good rea­son to be­lieve that they can take the same short cut.

Not­ed CEO Si­mon Mo­roney:

“We are very en­cour­aged by our most re­cent clin­i­cal da­ta from the on­go­ing L-MIND tri­al, which sup­port our plan to de­vel­op MOR208 in com­bi­na­tion with lenalido­mide as a chemo-free treat­ment op­tion for this pa­tient pop­u­la­tion.”

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.

Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.